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510(k) Data Aggregation

    K Number
    K021098
    Device Name
    DAUM-LECTRIC MRI DRILLING MACHINE
    Date Cleared
    2002-12-03

    (243 days)

    Product Code
    Regulation Number
    874.4250
    Why did this record match?
    Applicant Name (Manufacturer) :

    MRI DEVICES DAUM GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Daum p-lectric Drilling Machine is a piezoelectrically driven hand held drill intended to assist the surgeon to access bony tissue. The Daum p-lectric Drilling Machine can drill into hard and soft bone tissue to create a small hole or to obtain bony tissue samples. The Daum p-lectric Drilling Machine is designed to be used inside or close to an MRI Unit up to 1.5 Tesla.
    Device Description
    Not Found
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    K Number
    K010037
    Device Name
    DAUM DOUBLE-SHOOT BISOPSY GUN
    Manufacturer
    Date Cleared
    2001-03-22

    (77 days)

    Product Code
    Regulation Number
    876.1075
    Why did this record match?
    Applicant Name (Manufacturer) :

    DAUM GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Device Description
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    K Number
    K991366
    Device Name
    DAUM MRI/CONVENTIONAL BIOPSY KIT
    Manufacturer
    Date Cleared
    1999-06-25

    (66 days)

    Product Code
    Regulation Number
    876.1075
    Why did this record match?
    Applicant Name (Manufacturer) :

    DAUM GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Dasm MRI/Conventional Biopsy Set consists of two parts, the Daum BiopsyGun and the Daum CoaxNeedle. The BiopsyGun is used for automatic biopsy of soft tissues, and the CoaxNeedle is intended for use in open and percutaneous surgical procedures of the brain. The patented surface treatment of the needle optimizes its use in the MRI setting, producing a low-artifact visualization of the needle,
    Device Description
    The Dasm MRI/Conventional Biopsy Set consists of two parts, the Daum BiopsyGun and the Daum CoaxNeedle. The BiopsyGun is used for automatic biopsy of soft tissues, and the CoaxNeedle is intended for use in open and percutaneous surgical procedures of the brain. The patented surface treatment of the needle optimizes its use in the MRI setting, producing a low-artifact visualization of the needle,
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    K Number
    K990782
    Device Name
    DAUM NEUROGATE TROCAR
    Manufacturer
    Date Cleared
    1999-04-28

    (50 days)

    Product Code
    Regulation Number
    876.1075
    Why did this record match?
    Applicant Name (Manufacturer) :

    DAUM GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Daum NeuroGate Trocar is a reusable surgical instrument made of titanium, which is to be inserted into the skull. The insertion is done with the aid of an insertion tool. This trocar function is for inserting and fixing of needles and instruments. NeuroGate trocar is available with several channel diameters (I IG, 14G, 16G) allowing a combination with all Daum neuro needles.
    Device Description
    The Daum NeuroGate Trocar is a reusable surgical instrument made of titanium, which is to be inserted into the skull. The insertion is done with the aid of an insertion tool. This trocar function is for inserting and fixing of needles and instruments. NeuroGate trocar is available with several channel diameters (I IG, 14G, 16G) allowing a combination with all Daum neuro needles.
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    K Number
    K970037
    Device Name
    TARGOGRID
    Manufacturer
    Date Cleared
    1997-03-12

    (65 days)

    Product Code
    Regulation Number
    892.1000
    Why did this record match?
    Applicant Name (Manufacturer) :

    DAUM GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Device Description
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